BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SUPER SEAL

    K Number: K983477 · Decision Dec 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    76
    Applicant Total
    5
    Review Days
    81

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    Basic Information

    Device Name
    SUPER SEAL
    K Number
    K983477
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3250
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Phoenix Dental, Inc.
    Date Received
    October 2, 1998
    Decision Date
    December 22, 1998
    Product Code
    EJK
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EJK Liner, Cavity, Calcium Hydroxide

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